Class 1 Recall: Medtronic Inc. SynchroMed EL Implantable, Infusion Pump

August 3, 2007

Medtronic Inc. SynchroMed El Implantable, Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18.

The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

SynchroMed El pumps with motors manufactured before September 1999 are affected.

This device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories.

There is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors that were manufactured before September 1999. These pumps can stall at a higher rate due to gear shaft wear. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of drug underinfusion or withdrawal. Drug withdrawal from Intrathecal Baclofen (ITB) therapy (in the patient’s spine) can cause death if not treated immediately and effectively.

Consumers with questions may contact Medtronic Neuromodulation Patient Services at 1-800-510-6735.

Customers with technical questions may contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Beginning on August 3, 2007, Medtronic Inc. notified their customers with a letter entitled, "Urgent: Medical Device Correction, Aug. 2007." This letter described the problem and the affected devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178